Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

1,083

Participants

Timeline

Start Date

October 15, 2025

Primary Completion Date

June 1, 2030

Study Completion Date

December 31, 2030

Conditions
Locally Advanced Colorectal Cancer
Interventions
DRUG

Mitomycin (MM)

Mitomycin 30mg/m2/4 litres of perfusion liquid (dextrose 1.5%). Single intraoperative dose.

DRUG

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

FOLFOX6 consists in oxaliplatin 85 mg/m2 iv. on day 1, 5FU 400 mg/m2 iv. in bolus followed by 2400 mg/m2 in a continuous infusion for 46 hours. Leucovorin: 400mg/m2 folinic acid (racemid dl) in a continuous infusion for 2 hours. Repeat every 2 weeks. Haematological recovery to ANC \>1.5x109/L and platelets \>75x109/L should be ensured prior to Day 1 of each 14-day cycle.

PROCEDURE

Cytoreductive surgery

Cytoreductive surgery will be defined as complete tumour resection including oncologic colectomy and adjacent structures with suspicious of infiltration to achieve a R0, bilateral oophorectomy is recommended in post-menopausal women

Trial Locations (1)

14004

Hospital Universitario Reina Sofia, Córdoba

All Listed Sponsors
collaborator

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

OTHER

collaborator

Spanish Association of Surgeons (AEC)

OTHER

collaborator

Sociedad Española de Oncología Quirúrgica

OTHER

lead

Maimónides Biomedical Research Institute of Córdoba

OTHER